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Data Safety Monitoring Board (DSMB) Support

Active

Federal

Response Deadline12/18/2026, 09:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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This subcontract opportunity with the National Institutes of Health NICHD focuses on establishing and supporting the Data Safety Monitoring Board for pediatric trials. The selected provider will be responsible for developing Data Safety Monitoring Plans and managing communication systems for Serious Adverse and Adverse Event Reports to ensure full compliance with FDA requirements. Key deliverables include the production of safety monitoring reports and the documentation of DSMB meeting minutes. Qualified candidates must possess specialized experience in safety reporting specifically for pediatric populations. Interested parties should note that the response deadline for this effort is December 18, 2026. The contract falls under NAICS code 541611 and is designed to provide critical safety oversight for prime contractors conducting NIH pediatric research.

General Info

NIH NICHD subcontract for pediatric trial DSMB support and safety reporting by 12/18/2026.

Agency

Department Of Health And Human Services → National Institutes Of Health Nichd

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

MD, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N94026R00008.

The full solicitation package (4 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Best Pharmaceuticals for Children Act Data Coordination Center

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Timeline

PostedNov 3

subcontract

Response DeadlineDec 18

Submission deadline

Response Deadline

12/18/2026, 09:00:00 PM UTCin about 1 month

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nichd

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Nichd

Office AddressN/A

ContactsNo contact information available

Full Description

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Establishes and supports the Data Safety Monitoring Board for prime contractors on NIH/NICHD pediatric trials. Develops Data Safety Monitoring Plans and manages communication systems for Serious Adverse and Adverse Event Reports per FDA requirements. Requires experience in pediatric population safety reporting. Delivers safety monitoring reports and DSMB meeting minutes.

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